INDICATIONS, SAFETY, AND WARNINGS NIM-ECLIPSE E4 SYSTEM

INDICATIONS FOR USE

The NIM Eclipse™ E4 NS (neurophys) and SD (simplified design) System is designed to monitor the sensory and/or motor pathway functions of the central and peripheral nervous system during a wide variety of spinal and cranial surgical procedures. Surgeries using NIM-Eclipse SD and NIM‑Eclipse NS range from minimally invasive to traditional open surgeries in various locations of the body with peripheral and/or central nervous system involvement; for example, surgical spine procedures inclusive of the cervical, thoracic, lumbar and sacral regions along with correction of complex spinal deformity. Also, NIM‑Eclipse NS can be utilized in neurosurgical procedures that involve the brainstem and other cortical regions.

The NIM-Eclipse SD software platform is designed to be used by either Neurophysiology Clinicians, Technicians or Surgeons. The NIM‑Eclipse NS software platform is designed to be used by either Neurophysiology Clinicians or Technicians.


DEVICE DESCRIPTION

The NIM-Eclipse™ E4 System provides a dual-sided software in one platform: NS (neurophys) and SD (simplified-design).

NIM-Eclipse E4 SD is multimodal intraoperative neuromonitoring software which provides the user with various neurophysiological tests such as Transcranial Electrical Motor Evoked Potentials (TCeMEP), free running EMG, stimulated EMG and train of four (TOF) testing. The NIM-Eclipse E4 SD software platform is made up of 8 recording channels, proprietary TCeMEP stimulation connection, surgeon-controlled stimulation and software probe and train of four stimulation output. The NIM-Eclipse SD platform comes with an easy to use guide with color coordinated plug-in channels and stimulus outputs along with corresponding color coordinated recording needle and stimulating electrodes.

NIM‑Eclipse E4 NS is multimodal intraoperative neuromonitoring software which provides the user with various neurophysiological tests such as TCeMEP, Somatosensory Evoked Potentials (SEP), Electroencephalography (EEG), free running EMG, stimulated EMG, TOF, brainstem auditory evoked potentials, visual evoked potentials, cortical mapping, language mapping and other evoked potentials not listed here. The NIM‑Eclipse NS platform allows up to 32 channels of recording, 16 Hi-Electrical (100mA) stimulus outputs, 4 Hi-Voltage (1000V) outputs and 2 low-level stimulus outputs. 

The NIM‑Eclipse E4 NS and SD software is designed for maximum user flexibility and includes features such as pre-defined modality parameters for template building, drag and drop display for all windows, on-the-fly modality adding and adjusting without pausing or stopping data acquisition and built-in remote monitoring software to allow remoted clients to log-in and view, download data and communicate with the clinical E4 software in the operating room.


CONTRAINDICATIONS 

The use of paralyzing anesthetic agents will significantly reduce, if not completely eliminate, EMG responses to direct or passive nerve stimulation. Whenever nerve paralysis is suspected, consult an anesthesiologist.

Comprehensive relative contraindications of transcranial electrical motor evoked potentials (TCeMEP) include epilepsy, cortical lesions, convexity skull defects, raised intracranial pressure, cardiac disease, proconvulsant medications or anesthetics, intracranial electrodes, vascular clips or shunts, and cardiac pacemakers or other implanted biomedical devices. Otherwise unexplained intraoperative seizures and possibly arrhythmias are indications to abort TCeMEP.


WARNINGS, PRECAUTIONS, AND SAFETY CONSIDERATIONS

System Warnings 

W1

The NIM-Eclipse System does not prevent the surgical severing of nerves. If monitoring is compromised, the surgical practitioner must rely on alternate methods or surgical skills, experience, and anatomical knowledge to prevent damage to nerves.

W2

To avoid alternate site patient burns or lesions:

  • Do not activate electrosurgical instrument while the stimulator is in contact with tissue.
  • Do not leave stimulating electrodes or probes in surgical field.
  • Do not store stimulating electrodes or probes in electrosurgical instrument holder.
  • Do not allow a second surgeon (i.e. fat harvesting) to use electrosurgical instrument while stimulator is in use.
  • Do not activate electrosurgical instrument for prolonged periods while ESU is not in contact with tissue.
  • Do not activate electrosurgical instrument near the recording or stimulating electrodes.
  • Do not allow patient interface boxes or recording/stimulating electrodes sites to be flooded with saline.
  • Do not allow excessive stray AC or DC leakage currents from patient-connected equipment; avoid creating an unintended grounding path through applied electrodes.

W3

Practitioner is responsible for proper use, periodic safety certification of patient connected equipment, and AC power grounding in accordance to appropriate IEC 60601-1 and/or IEC6061 medical safety standard.

W4

Special operator attention may be required for stimulus currents exceeding 2 mA RMS/cm2. The RMS value of current is generally lower than the stimulator current setting in mA. To calculate RMS current, waveform morphology, pulse width, repetition rate, and the stimulator current delivered must be considered.

W5

When using the TCD, do not exceed 5% power through the eye, burr holes, fontanelles or foramen magnum. Always start the TCD exam at 5% power and observe the ALARA principle by limiting power levels to As Low As Reasonably Achievable.

W6

If NIM-Eclipse System accessories are used with stimulators other than the System, do not exceed an energy level of 50 mJ per pulse (measured into a 1 kilo-ohm load).

W7

While Muting is activated, auditory and visual monitoring are disabled.

W8

To avoid false negative responses, verify stimulator current setting is high enough, and verify stimulus delivery by observing measured patient current. Low stimulator current may cause a false negative response.

W9

High stimulator current and/or transcranial motor stimulation may cause involuntary patient movement resulting in patient injury.

W10

High stimulator current and/or transcranial motor stimulation activating of the fifth cranial nerve or Mastication muscles may cause tongue lacerations.

W11

Do not use this instrument for either direct stimulation to, or direct recording from, the heart. Do not use for trans-thoracic stimulation.

W12

Do not stimulate a patient with an implanted cardiac pacemaker or similar implanted device without the approval of a licensed medical practitioner. 

W13

Do not use high level electrical or TCeMEP stimulation to directly stimulate an exposed nerve.

W14

High level electrical stimulators can produce outputs of 400V @ 100mA. Use electrodes with appropriate surface area to ensure safe current densities. Do not use a needle electrode for patient ground.

W15

Avoid prolonged use of high sound pressure levels or light intensity stimulation which may cause permanent hearing or visual impairment. 

W16

LED goggles for flash stimulation should be used with closed eyes only.

W17

False negative responses (failure to locate nerve) may result from:

  • Shorted EMG electrode or cabling (conductive parts of applied needle electrodes or cables contacting each other).
  • Inadequate stimulus current.
  • Inadequate current for stimulation of nerve through hardware, such as pedicle screws or stimulus dissection instruments, may vary based on the physical size, shape characteristics, and design of the hardware and proximity to the nerve.
  • Neuromuscular fatigue from prolonged or repeated exposure to electrical stimuli.
  • Inadvertent simultaneous current delivery from both Stimulator (Patient Interface) probe outputs. This may result in current shunting, division between the stimulator probes (this is referring to monopolar probes only).
  • Shorted internal amplifier (characterized by baseline activity of < 3 μV p-p).
  • Improper placement of recording and/or stimulating electrodes.

W18

Do not power-on the NIM-Eclipse System when the stimulator is in the surgical field.

W19

To avoid the risk of fi re or explosion, do not use the NIM-Eclipse System in the presence of flammable anesthetics and/or oxygen-rich environments.

W20

To avoid electrical shock, do not attach unapproved components or accessories to the NIM-Eclipse System.

W21

Direct stimulator contact may disrupt the operation of active implanted devices.

W22

Proper handling, insertion, and placement of electrodes and probes is critical for safe and accurate monitoring.

W23

Improperly placed or bent needles increase the risk of needles breaking off in the patient.

W24

Do not attempt to straighten bent needles because this may cause stress and weaken device, causing needles to break off in patient.

W25

Extreme care must be taken when handling instruments with sharp points or edges.

W26

The surgical practitioner must choose the appropriate size and locations of electrodes and probes based on the procedure to be performed and the stimulating current necessary for the application.

W27

Avoid trans-thoracic stimulation; when possible, maintain anode and cathode stimulating sites in close proximity.

W28

Reuse of single use electrodes and probes increase the risk of infection and may cause degraded or ineffective monitoring.

PRECAUTIONS

P1

To avoid loud, extraneous monitoring noise during electrosurgical unit activation, ensure the Muting Probe is properly attached to the active electrosurgical lead.

P2

Inadequate stimulus current flow may be caused by non-flush contact between the stimulating electrode or probe and the nerve, inadequate stimulator probe electrical contact surface area, or high impedance.

P3

Inability to deliver stimulus current flow may be caused by:

  • Stimulator return electrode is not connected, or other incomplete electrical connection between the NIM-Eclipse System, monitoring electrode and stimulator probe.
  • Stimulus set to 0 mA.
  • Defective stimulating electrode or probe.

P4

To avoid false positive EMG events (stimulus artifacts):

  • Ensure the recording electrodes and the stimulator (+) or (-) cabling are routed separately and not tangled.
  • When possible, ensure the EMG ground (green wire) is physically placed between the stimulator return electrode and the EMG channel input electrodes.

P5

Proper placement and setup of the electrosurgical unit away from the NIM-Eclipse System will reduce or minimize unnecessary muting, interference, and off sets.

P6

Use of unapproved stimulators, stimulus probes, stimulus-dissection instruments or electrodes may result in compromised NIM-Eclipse System operation, such as, but not limited to, decreased accuracy.

P7

Electrode impedance should be checked after electrode insertion and before electrode removal to give additional assurance that electrode continuity was maintained throughout the entire procedure. If electrode impedance is very high, discontinue use and replace.

P8

The Patient Interface cables and Muting Probe cable should be secured to the floor with tape or other non-trip device.

P9

To avoid excessive muting:

  • Avoid high-power electrosurgical unit monopolar settings. Note that muting caused by electrode charging may last several seconds after electrosurgical Instrument use.
  • Avoid accidental contact between connected but unapplied electrodes and other conductive parts.

P10

Contaminated single use electrodes and probes must be disposed of in an appropriate sharps biohazard container in accordance with hospital or other user facilities policy.

P11

To ensure proper operation of this instrument, read all documents, instructions and labels.

P12

This equipment is not liquid or splash proof. Erratic operation or permanent damage can result if water or liquids enter any of the electronic portions of this equipment.

P13

Do not modify, change, alter or delete the software in this equipment. Third party software may interfere with proper operation of this medical device. Do not install any off -the-shelf software without first consulting the factory. Installing unapproved software may void the warranty

P14

Automatic updates of Windows and Anti-Virus software have been disabled to prevent updating during a monitored procedure. However the user will continue to be notified when software updates are available to be downloaded. Always install new updates as soon as is practically possible to ensure your system is current.

P15

Non-medical equipment approved to an appropriate standard (like IEC 60950) may be connected to the System I/O and auxiliary mains output provided that the total leakage current meets the requirements of IEC 60601-1. If not, an IEC 60601-1 approved isolation transformer with appropriate ratings must be used. Consult the factory for additional details.

ADDITIONAL PRECAUTIONS

AP16

To avoid system damage, do not connect any device other than NIM-Eclipse System accessories into the inputs on the rear panel of the NIM-Eclipse System controller.

AP17

Disconnect the power cord of the NIM-Eclipse System or a connected printer before cleaning. To prevent cleaning solutions from seeping into the electronic portions of the instrument, spray cleaner lightly on a cotton cloth, then wipe the instrument with the cloth. Be especially careful around the controls, connectors and panel edges. Do not use abrasive cleaners (especially on the monitor screen).

AP18

This system does not contain repairable components. Repair and/or modification to the NIM-Eclipse System or any accessory by anyone other than qualified service personnel may significantly compromise the unit’s ability to monitor nerve activity and/or void the equipment warranty. For best performance, it is recommended that all service be performed by Medtronic service personnel. When the protective covers are removed from any system component, main console, stimulator, etc., hazardous voltages may be exposed.

AP19

Reasonable care should be made in making electrical connections and handling electrically powered devices. Do not use damaged electrical equipment or frayed electrical cords. During repair or maintenance, turn off the NIM-Eclipse System and disconnect the power.

AP20

The NIM-Eclipse System operates from power sources of 50 to 60 Hz at 100/240 VAC. Use only hospital-grade power cords and the connectors supplied with the NIM-Eclipse System. Be sure power cords and connectors are in good condition. Never apply a voltage to the equipment that is outside the range specified for its connectors.

AP21

Connection of equipment not tested and or not found in conformance with the IEC60601-1 MEDICAL DEVICES AND APPLIANCES standards is strictly prohibited.

AP22

Avoid accidental contact between connected but unapplied parts (Devices which can be connected to the patient) and other conductive parts including those connected to protective earth.

AP23

To avoid electrical and fi re hazard, use only recommended fuses. Fuses must match by type, voltage rating, and current rating.

AP24

The NIM-Eclipse System provides no explosion protection from static discharge or arcing components. Do not operate the unit in the presence of explosive gases such as flammable mixtures of anesthetic and air or nitrous oxide.

AP25

To prevent overheating, keep ventilation holes free from obstruction.

AP26

Do not connect USB devices to the system while a test is running.

AP27

At the end of their life cycle, all NIM-Eclipse system electronic components must be sent to a WEEE recycling center or disposed of according to local regulations.

 SAFETY CONSIDERATIONS

The following safety considerations apply to the use of the System for Intraoperative Monitoring (IOM). These guidelines should be followed to ensure that the System is operated safely at all times.

  1. Verify that the Electro Surgical Unit’s (ESU) dispersive pad return electrode is properly applied to the patient. Many ESU units will signal the surgeon when the dispersive pad is not making good contact with the patient. However, it is important to confirm this by visual inspection to ensure that return currents will flow directly to the pad. Do not activate the ESU for prolonged periods when the ESU pencil is not in direct contact with the patient. Radio Frequency (RF) leakage currents are most hazardous when the ESU pencil is activated, but not yet in contact with the patient. During this time, leakage currents may flow through the patient and return to earth ground through the lowest resistance path. Prolonged activation may cause leakage current to produce localized tissue heating.
  2. Avoid ESU pencil use close to the monitoring or stimulation electrodes. Activating the ESU pencil in the vicinity of the patient electrodes will increase the probability of leakage currents flowing in the electrodes.
  3. Use a large area ground electrode for the patient ground. Reducing the leakage current density (Amps/Area) will reduce the possibility of leakage currents flowing in the electrodes.